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目的:研究克拉霉素软胶囊在健康人体生物等效性。方法:18名健康男性志愿者随机交叉口服单剂量(0.5g)克拉霉素软胶囊受试制剂或克拉霉素片参比制剂,HPLC-MS法测定血药浓度,计算药动学参数和相对生物利用度,评价其生物等效性。结果:受试制剂和参比制剂的主要药动学参数如下:tmax分别为(2.3±0.8)和(2.1±1.0)h,Cmax分别为(2.2±0.7)和(2.3±0.8)mg.L-1,t1/2分别为(3.7±0.5)和(4.1±0.5)h,AUC0-24分别为(14.9±4.7)和(15.6±6.0)mg.h.L-1,AUC0-∞分别为(15.1±4.8)和(16.0±6.0)mg.h.L-1。受试制剂的相对生物利用度F0-t为(98.4±15.0)%,F0-∞为(97.6±14.8)%。结论:克拉霉素软胶囊受试制剂与参比制剂具有生物等效性。
Objective: To study the bioequivalence of clarithromycin capsules in healthy volunteers. Methods: Eighteen healthy male volunteers were randomized to receive a single dose (0.5g) of clarithromycin soft capsule or clarithromycin tablet at randomized crossover point. The plasma concentration was determined by HPLC-MS. The pharmacokinetic parameters and relative Bioavailability, evaluate its bioequivalence. RESULTS: The main pharmacokinetic parameters of the test and reference preparations were as follows: tmax was (2.3 ± 0.8) and (2.1 ± 1.0) h and Cmax was (2.2 ± 0.7) and (2.3 ± 0.8) mg.L (3.7 ± 0.5) and (4.1 ± 0.5) h respectively, AUC0-24 were (14.9 ± 4.7) and (15.6 ± 6.0) mg.hL-1, respectively, and AUC0- ± 4.8) and (16.0 ± 6.0) mg.hL-1. The relative bioavailability of the tested preparations was F0-t (98.4 ± 15.0)% and F0-∞ was (97.6 ± 14.8)%. Conclusion: The clarithromycin soft capsule formulation is bioequivalent to the reference formulation.